GUIDELINE INDEX
BATCH Q: Quality
Finalised Guidelines (Step 4)
Q1A(R2)
Stability Testing of New Drug Substances and Products (Second Revision)
Feb. 2003
Q1B
Stability Testing: Photostability Testing of New Drug Substances and Products
Nov. 1996
Q1C
Stability Testing for New Dosage Forms
Nov. 1996
Q1D
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and
Products
Feb. 2002
Q1E
Evaluation for Stability Data
Feb. 2003
Q1F*
Stability Data Package for Registration Applications in Climatic Zones III and IV
(Guideline withdrawn in June 2006).
Feb. 2003
Q2(R1)
Validation of Analytical Procedures: Text and Methodology
(The Addendum dated November 1996 has been incorporated into the core guideline in
November 2005).
Oct. 1994
Q3A(R2)
Impurities in New Drug Substances
Oct. 2006
Q3B(R2)
Impurities in New Drug Products
June 2006
Q3C(R5)
Impurities: Guideline for Residual Solvents (including the two Revised PDE for THF and
NMP dated September 2002 and October 2002 incorporated in core Guideline in
November 2005 and revised PDE for Cumene incorporated in core Guideline in February
2011)
Feb. 2011
Q3D
Guideline for Elemental Impurities
Dec. 2014
Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Nov. 2007
Q4B
Annex 1(R1)
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Residue on Ignition/Sulphated Ash General Chapter
Sept. 2010
Q4B
Annex 2(R1)
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Test for Extractable Volume of Parenteral Preparations General Chapter
Sept. 2010
Q4B
Annex 3(R1)
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Test for Particulate Contamination: Sub-Visible Particles General Chapter
Sept. 2010
Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Annex 4A(R1) Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
General Chapter
Sept. 2010
Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Annex 4B(R1) Microbiological Examination of Non-Sterile Products: Tests for Specified MicroOrganisms General Chapter
Sept. 2010
Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Annex 4C(R1) Microbiological Examination of Non-Sterile Products: Acceptance Criteria for
Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Sept. 2010
Q4B
Annex 5(R1)
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Disintegration Test General Chapter
Sept. 2010
Q4B
Annex 6
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
University of Dosage Units General Chapter
Nov. 2013
Q4B
Annex 7(R2)
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Dissolution Test General Chapter
Nov. 2010
ICH Guidelines Index
Q4B
Annex 8(R1)
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Sterility Chapter General Chapter
Sept. 2010
Q4B
Annex 9(R1)
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Tablet Friability General Chapter
Sept. 2010
Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Annex 10(R1) Polyacrylamide Gel Electrophoresis General Chapter
Sept. 2010
Q4B
Annex 11
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Capillary Electrophoresis General Chapter
June 2010
Q4B
Annex 12
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Analytical Sieving General Chapter
June 2010
Q4B
Annex 13
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Bulk Density and Tapped Density of Powders General Chapter
June 2012
Q4B
Annex 14
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Bacterial Endotoxins Test General Chapter
Oct. 2012
Q5A(R1)
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or
Animal Origin
Sept. 1999
Q5B
Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used
for Production of r-DNA Derived Protein Products
Nov. 1995
Q5C
Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological
Products
Nov. 1995
Q5D
Derivation and Characterisation of Cell Substrates Used for Production of
Biotechnological/
Biological Products
Q5E
Comparability of Biotechnological/Biological Products Subject to Changes in Their
Manufacturing Process
Nov. 2004
Q6A
Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and
New Drug Products : Chemical Substances
Oct. 1999
Q6B
Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological
Products
Mar. 1999
Q7
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Nov. 2000
Q8(R1)
Pharmaceutical Development
Nov. 2008
Q9
Quality Risk Management
Nov. 2005
Q10
Pharmaceutical Quality System
June 2008
Q11
Development and Manufacture of Drug Substances (Chemical Entities and
Biotechnological/Biological Entities)
May 2012
Jul. 1997
Guidelines released for consultation (Step 2b)
July 2013
ICH Guidelines Index
BATCH S: Safety
Finalised Guidelines (Step 4)
S1A
Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
S1B
Testing for Carcinogenicity of Pharmaceuticals
July 1997
S1C(R2)
Dose Selection for Carcinogenicity Studies of Pharmaceuticals
Mar. 2008
S2(R1)
Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for
Human Use
Nov. 2011
S3A
Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
Oct. 1994
S3B
Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
Oct. 1994
S4
Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
Sept. 1998
S5(R2)
Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (the
Addendum dated November 1995 has been incorporated into the core guideline in November
2005)
June 1993
S6(R1)
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
June 2011
S7A
Safety Pharmacology Studies for Human Pharmaceuticals
Nov. 2000
S7B
The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT
Interval Prolongation) by Human Pharmaceuticals
May 2005
S8
Immunotoxicity Studies for Human Pharmaceuticals
Sept. 2005
S9
Nonclinical Evaluation for Anticancer Pharmaceuticals
Oct. 2009
S10
Photosafety Evaluation
Nov. 2013
Guidelines released for consultation (Step 2b)
Nov. 1995
ICH Guidelines Index
BATCH E: Efficacy
Finalised Guidelines (Step 4)
E1
The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for
Long-Term Treatment of Non-Life-Threatening Conditions
Oct. 1994
E2A
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
Oct. 1994
E2B(R3)
Implementation Guide
Clinical Safety Data Management: Data Elements for Transmission of Individual Case
Safety Reports
Nov. 2014
E2C(R2)
Periodic Benefit-Risk Evaluation Report
Nov. 2012
E2C(R2)
Q&As
Periodic Benefit-Risk Evaluation Report – Questions & Answers
Mar. 2014
E2D
Post-Approval Safety Data Management: Definitions and Standards for Expedited
Reporting
Nov. 2003
E2E
Pharmacovigilance Planning
Nov. 2004
E2F
Development Safety Update Report
Aug. 2010
E3
Structure and Content of Clinical Study Reports
Nov. 1995
E3
Q&As (R1)
Structure and Content of Clinical Study Reports – Questions & Answers
July 2012
E4
Dose-Response Information to Support Drug Registration
Mar. 1994
E5(R1)
Ethnic Factors in the Acceptability of Foreign Clinical Data
Mar. 1998
E6(R1)
Good Clinical Practice: Consolidated Guideline
May 1996
E7
Studies in Support of Special Populations: Geriatrics
June 1993
E7 Q&As
Studies in Support of Special Populations: Geriatrics – Questions & Answers
July 2010
E8
General Considerations for Clinical Trials
July 1997
E9
Statistical Principles for Clinical Trials
Feb. 1998
E10
Choice of Control Group and Related Issues in Clinical Trials
July 2000
E11
Clinical Investigation of Medicinal Products in the Pediatric Population
July 2000
E14
The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic Drugs
May 2005
E14
Q&As (R2)
The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic Drugs – Questions and Answers
Mar. 2014
E15
Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics,
Genomic Data and Sample Coding Categories
Nov. 2007
E16
Biomarkers Related to Drug or Biotechnology Product Development: Context,
Structure and Format of Qualification Submissions
Aug. 2010
Documents released for consultation (Step 2b)
Consensus Draft Principle
E12
Principles for Clinical Evaluation of New Antihypertensive Drugs
Mar. 2000
ICH Guidelines Index
BATCH M: Multidisciplinary
Finalised Guidelines (Step 4)
M2 ICSR (R2)
Electronic Transmission of Individual Case Safety Reports Message Specification (ICH
ICSR DTD Version 2.1) companion document to E2B(R3)
Feb. 2001
M3(R2)
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals
June 2009
M3(R2) Q&As (R2)
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals Questions & Answers
Mar. 2012
M4(R3)*
Organisation of the Common Technical Document for the Registration of
Pharmaceuticals for Human Use (Edited with Numbering and Section Header
Changes, September 2002)
Including the Annex : the Granularity Document (Revised November 2003).
Nov. 2000
M4Q(R1)*
The Common Technical Document for the Registration of Pharmaceuticals for Human
Use : Quality (Edited with Numbering and Section Header Changes, September
2002)
Nov. 2000
M4S(R2)*
The Common Technical Document for the Registration of Pharmaceuticals for Human
Use : Safety (Edited with Numbering and Section Header Changes, September 2002)
Nov. 2000
M4E(R1)*
The Common Technical Document for the Registration of Pharmaceuticals for Human
Use : Efficacy (Edited with Numbering and Section Header Changes, September
2002)
Nov. 2000
M7
Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals
to Limit Potential Carcinogenic Risk
June 2014
Guidelines released for consultation (Step 2b)
*
Notice for Clarification:
Within the ICH regions, local versions are published. The wording of the core CTD (Modules 2, 3, 4 and 5) in
the local versions might be slightly different from one region to another due to specific editing that takes into
consideration regional regulations. It does not affect the common understanding by the six ICH parties of the
CTD published on the ICH website (http://www.ich.org).
Questions & Answers:
In order to facilitate the implementation of the CTD, the ICH Experts have developed a series of Q&As which
are continuously updated and can be downloaded from the ICH website directly from the following url:
http://www.ich.org/products/ctd.html